Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors
Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain foreign material, specifically black particles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The presence of foreign material (black particles) in a sterile medical device package represents a contamination risk, but the source text does not report any specific injuries, illnesses, or deaths, placing this in the Moderate category rather than Severe or Critical.
Plain-English summary
Teleflex Medical is recalling the Aquapak 640 SW, 650ML W/040 Adaptor, French. This medical device accessory is used to connect sterile water or sterile saline to a humidifier circuit for inhalation therapy. The recall involves 15,779,607 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the packages may contain foreign material, specifically black particles. The affected product code is 006-40F. Specific lot numbers involved in this recall include 147136, 103146, 015146, 102136, 153136, 023146, 040146, 001146, 056146, 115136, 052146, 132136, 008146, 110136, 159136, 165136, and 014146.
Healthcare providers and consumers should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to Teleflex Medical or the original supplier for credit or replacement.
The recalled product
- Product
- AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 15,779,607
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- Product Code: 006-40F
- Lot numbers: 147136
- 103146
- 015146
- 102136
- 153136
- 023146
- 040146
- 001146
- 056146
- 115136
- 052146
- 132136
- 008146
- 110136
- 159136
- 165136 & 014146.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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